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Efficacy and Safety of Petrelintide in Adults with Overweight or Obesity and Type 2 Diabetes: A Phase III Randomized Placebo‑Controlled Trial

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people who have Overweight or Obesity and Type 2 Diabetes. These conditions mean extra body weight and high blood sugar that does not improve with diet alone. The trial is testing a new injection called petrelintide (code name RO7895515) compared with a placebo. The goal is to see if the medication helps reduce body weight over time.

Participants will receive a subcutaneous injection once a week for about a year. They will have regular visits where simple measurements are taken, such as weight, waist circumference, and a calculation of BMI, which relates weight to height. Blood samples will be checked for things like fasting glucose (blood sugar after not eating), HDL cholesterol (the “good” cholesterol), and triglycerides (a type of fat). Blood pressure will be recorded, including the systolic blood pressure (the top number). Safety will be monitored by looking for any adverse events, checking for anti‑drug antibodies (the body’s response to the medication), and performing a simple heart test called an ECG. The study follows participants for 64 weeks to determine the overall effect.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Assessment and Randomization

    After enrollment, you will attend a baseline visit where your body weight, waist size, blood pressure, and blood samples will be measured.

    You will be randomly assigned to receive either petrelintide or a matching placebo. Both are given as a subcutaneous (under‑the‑skin) injection.

  2. Step 2

    Start of Weekly Injections

    You will begin receiving one injection each week for a total of 64 weeks.

    The injection is administered under the skin and the amount is defined by the study protocol.

    If you are assigned to the placebo, the injection contains no active drug.

  3. Step 3

    Ongoing Safety Monitoring

    Throughout the study you will be asked to report any side effects or health changes you notice.

    Periodic clinic visits may be scheduled so that staff can check your vital signs, repeat blood tests, and review your overall health.

  4. Step 4

    Final Assessment at Week 64

    At the end of week 64 you will return for a final visit where the same measurements taken at baseline will be repeated, including body weight, waist circumference, blood pressure, and laboratory tests.

    Blood samples will also be taken to measure the level of petrelintide in your body and to check for any antibodies that might have formed against the drug.

    The study team will evaluate the change in your body weight and other health indicators compared with the baseline values.

  5. Step 5

    Study Completion

    After the final assessments, you will stop receiving the study injection.

    You may be offered guidance on continuing care for your weight and diabetes, but the study drug will no longer be provided.

Who can join the trial?

4 criteria

  • Be able and willing to follow all study requirements, such as attending visits, completing questionnaires, and doing all required tests for the whole study period.
  • Be at least 18 years old when signing the Informed Consent Form (the document that explains the study and records your permission to join).
  • Have a Body Mass Index (BMI) of 27.0 or higher. BMI is a number that compares your weight to your height and helps show if you are overweight.
  • Have tried at least one diet plan on your own that did not lead to lasting weight loss.

Who cannot join the trial?

1 criterion

  • Anyone who is currently taking or has ever taken petrelintide or any other amylin analog (medicines that work like the natural hormone amylin) cannot join the study.
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Investigated drugs

RO7895515 is a medication that contains the active ingredient petrelintide. It is given as a solution that is injected under the skin (subcutaneous injection). In this study participants receive the injection once each week. The purpose of the medication is to help people who are overweight or obese and have type 2 diabetes lose body weight. The trial is checking how well the medication works for weight loss and whether it is safe to use.

What is already known about the treatment

Petrelintide - It is supplied as a clear solution for injection that is given under the skin (subcutaneous) once a week. The drug is still investigational and is being studied in clinical trials for people who are overweight or have obesity together with type 2 diabetes. It works by binding to specific receptors in the brain that help reduce appetite and increase the body’s use of energy, which can lead to weight loss. Petrelintide belongs to the class of peptide hormone analogs that act like natural signals controlling food intake.

Investigated diseases

  • Obesity

    Obesity is a condition characterized by excess body fat that accumulates over time. It usually develops gradually as calorie intake consistently exceeds energy expenditure. As weight increases, the body may find it harder to lose weight without specific interventions. The condition can persist and worsen if lifestyle factors remain unchanged.

  • Type 2 diabetes mellitus

    Type 2 diabetes mellitus is a disorder where the body does not use insulin effectively, leading to elevated blood sugar levels. It often begins with mild insulin resistance and progresses to higher glucose concentrations if not managed. Over time, the pancreas may produce less insulin as the disease advances. The condition can become more pronounced with ongoing metabolic stress.

Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526189-25-00Protocol codeCC46369Estimated enrolment644 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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